Back to resultsMultiple CoolSculpting Treatment Study
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Zeltiq CoolSculpting System
Sponsored by
About this trial
This is an interventional other trial for Body Fat Disorder focused on measuring Lipolysis, Cryolipolysis, Fat Reduction
Eligibility Criteria
Inclusion Criteria
- Male or female subjects > 18 years of age.
Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
- Lower Abdomen - One 60 minute cycle with CoolMax,
- Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Exclusion Criteria
- Subject has had an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a history of hernia in the area(s) to be treated.
- Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
- Subject is lactating or has been lactating during the past 3 months.
- Subject is unable or unwilling to comply with the study requirements, such as blood draw.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Subject has a history of lipodosis or other confounding metabolic diseases.
- Subject is taking or has taken medication within the past 3 months which may affect the metabolic function.
- Patient has a history of diabetes.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Sites / Locations
- Innovation Research Center
- Ed Becker, MD
- Bowes Dermatology Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CoolSculpting Treatment Group
Arm Description
CoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized at protocol-defined temperatures and durations.
Outcomes
Primary Outcome Measures
Evaluation of Liver- Related Tests Over Time
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Evaluation of Liver-Related Tests Over Time
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Evaluation of Serum Lipid Values Over Time
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Secondary Outcome Measures
Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.
Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit.
Side Effects in Treatment Area
Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01814007
Brief Title
Multiple CoolSculpting Treatment Study
Official Title
Safety Evaluation of Multiple CoolSculpting Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 22, 2013 (Actual)
Study Completion Date
October 22, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.
Detailed Description
The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CoolSculpting Treatment Group
Arm Type
Experimental
Arm Description
CoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized at protocol-defined temperatures and durations.
Intervention Type
Device
Intervention Name(s)
The Zeltiq CoolSculpting System
Other Intervention Name(s)
Cryolipolysis, Lipolysis
Intervention Description
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Primary Outcome Measure Information:
Title
Evaluation of Liver- Related Tests Over Time
Description
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Time Frame
Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
Title
Evaluation of Liver-Related Tests Over Time
Description
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Time Frame
Pretreatment, 1 week, 4 weeks 12 weeks post-treatment
Title
Evaluation of Serum Lipid Values Over Time
Description
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Time Frame
Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment
Title
Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
Description
The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Time Frame
12 weeks post treatment
Secondary Outcome Measure Information:
Title
Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
Description
All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.
Time Frame
12 weeks post-treatment
Title
Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
Description
Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit.
Time Frame
Treatment day and 12 week post-treatment follow-up
Title
Side Effects in Treatment Area
Description
Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe.
Time Frame
Treatment day and 12 week post-treatment follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Male or female subjects > 18 years of age.
Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
Lower Abdomen - One 60 minute cycle with CoolMax,
Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously.
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
Subject agrees to not making any major changes in their diet or lifestyle during the course of the study.
Subject has read and signed a written informed consent form.
Exclusion Criteria
Subject has had an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject has a history of hernia in the area(s) to be treated.
Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
Subject is lactating or has been lactating during the past 3 months.
Subject is unable or unwilling to comply with the study requirements, such as blood draw.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Subject has a history of lipodosis or other confounding metabolic diseases.
Subject is taking or has taken medication within the past 3 months which may affect the metabolic function.
Patient has a history of diabetes.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bachelor, MD
Organizational Affiliation
Innovation Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovation Research Center
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Ed Becker, MD
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Bowes Dermatology Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5573959/
Description
Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests
Learn more about this trial
Multiple CoolSculpting Treatment Study
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